Guidewire having linear change in stiffness

ABSTRACT

The invention is directed to a guidewire having a distal section with multiple distally tapered core segments with at least two contiguous distally tapering core segments in which the most distal tapered core segment preferably has a greater degree of taper than the proximally contiguous tapered core segment. The invention is also directed to an elongated intracorporeal device, preferably a guidewire or section thereof, that has a core member or the like with a plurality of contiguous tapered segments having taper angles that are configured to produce a linear change in stiffness over a longitudinal section of the device. The device may also have a core section with a continuously changing taper angle to produce a curvilinear profile that preferably is configured to produce a linear change in stiffness of the core over a longitudinal section of the device.

RELATED APPLICATIONS

This application is a continuation in part of co-pending applicationSer. No. 08/868,764, filed Jun. 4, 1997, which is incorporated herein inits entirety.

BACKGROUND OF THE INVENTION

This invention relates to the field of guidewires for advancingintraluminal devices such as stent delivery catheters, balloondilatation catheters, atherectomy catheters and the like within bodylumens.

In a typical coronary procedure a guiding catheter having a preformeddistal tip is percutaneously introduced into a patient's peripheralartery, e.g. femoral or brachial artery, by means of a conventionalSeldinger technique and advanced therein until the distal tip of theguiding catheter is seated in the ostium of a desired coronary artery.There are two basic techniques for advancing a guidewire into thedesired location within the patient's coronary anatomy, the first is apreload technique which is used primarily for over-the-wire (OTW)devices and the bare wire technique which is used primarily for railtype systems. With the preload technique, a guidewire is positionedwithin an inner lumen of an OTW device such as a dilatation catheter orstent delivery catheter with the distal tip of the guidewire justproximal to the distal tip of the catheter and then both are advancedthrough the guiding catheter to the distal end thereof. The guidewire isfirst advanced out of the distal end of the guiding catheter into thepatient's coronary vasculature until the distal end of the guidewirecrosses the arterial location where the interventional procedure is tobe performed, e.g. a lesion to be dilated or a dilated region where astent is to be deployed. The catheter, which is slidably mounted ontothe guidewire, is advanced out of the guiding catheter into thepatient's coronary anatomy over the previously introduced guidewireuntil the operative portion of the intravascular device, e.g. theballoon of a dilatation or a stent delivery catheter, is properlypositioned across the arterial location. Once the catheter is inposition with the operative means located within the desired arteriallocation, the interventional procedure is performed. The catheter canthen be removed from the patient over the guidewire. Usually, theguidewire is left in place for a period of time after the procedure iscompleted to ensure reaccess to the arterial location is it isnecessary. For example, in the event of arterial blockage due todissected lining collapse, a rapid exchange type perfusion ballooncatheter such as described and claimed in U.S. Pat. No. 5,516,336(McInnes et al), can be advanced over the in-place guidewire so that theballoon can be inflated to open up the arterial passageway and allowblood to perfuse through the distal section of the catheter to a distallocation until the dissection is reattached to the arterial wall bynatural healing.

With the bare wire technique, the guidewire is first advanced by itselfthrough the guiding catheter until the distal tip of the guidewireextends beyond the arterial location where the procedure is to beperformed. Then a rail type catheter, such as described in U.S. Pat. No.5,061,395 (Yock) and the previously discussed McInnes et al. which areincorporated herein by reference, is mounted onto the proximal portionof the guidewire which extends out of the proximal end of the guidingcatheter which is outside of the patient. The catheter is advanced overthe catheter, while the position of the guidewire is fixed, until theoperative means on the rail type catheter is disposed within thearterial location where the procedure is to be performed. After theprocedure the intravascular device may be withdrawn from the patientover the guidewire or the guidewire advanced further within the coronaryanatomy for an additional procedure.

Conventional guidewires for angioplasty, stent delivery, atherectomy andother vascular procedures usually comprise an elongated core member withone or more tapered sections near the distal end thereof and a flexiblebody such as a helical coil or a tubular body of polymeric materialdisposed about the distal portion of the core member. A shapable member,which may be the distal extremity of the core member or a separateshaping ribbon which is secured to the distal extremity of the coremember extends through the flexible body and is secured to the distalend of the flexible body by soldering, brazing or welding which forms arounded distal tip. Torquing means are provided on the proximal end ofthe core member to rotate, and thereby steer, the guidewire while it isbeing advanced through a patient's vascular system.

Further details of guidewires, and devices associated therewith forvarious interventional procedures can be found in U.S. Pat. No.4,748,986 (Morrison et al.); U.S. Pat. No. 4,538,622 (Samson et al.):U.S. Pat. No. 5,135,503 (Abrams); U.S. Pat. No. 5,341,818 (Abrams etal.); U.S. Pat. No. 5,345,945 (Hodgson, et al.) and U.S. Pat. No.5,636,641 (Fariabi) which are hereby incorporated herein in theirentirety by reference thereto.

For certain procedures, such as when delivering stents aroundchallenging take-off, e.g. a shepherd's crook, tortuosities or severeangulation, substantially more support and/or vessel straightening isfrequently needed from the guidewire than normal guidewires can provide.Guidewires have been commercially introduced for such procedures whichprovide improved distal support over conventional guidewires, but suchguidewires are not very steerable and in some instances are so stiffthat they can damage vessel linings when advanced therethrough. What hasbeen needed and heretofore unavailable is a guidewire which provides ahigh level of distal support with acceptable steerability and littlerisk of damage when advanced through a patient's vasculature.

In addition, conventional guidewires using tapered distal core sectionsas discussed above can be difficult to use in many clinicalcircumstances because they have an abrupt stiffness change along thelength of the guidewire, particularly where the tapered portion beginsand ends. As a guidewire having a core with an abrupt change instiffness is moved through tortuous vasculature of a patient, thephysician moving the guidewire can feel the abrupt resistance as thestiffness change is deflected by the curvature of the patient'svasculature. The abrupt change in resistance felt by the physician canhinder the physician's ability to safely and controllably advance theguidewire through the vasculature. What has been needed is a guidewire,and particularly a guidewire core member, that does not have an abruptchange in stiffness, particularly in the portions of the distal sectionthat are subject to bending in the vasculature and guiding catheter. Thepresent invention satisfies these and other needs.

SUMMARY OF THE INVENTION

The present invention is directed to an improved guiding deviceproviding enhanced distal support while having a flexible distal tip toprovide acceptable steerability and little risk of damage to vessel orchamber linings when advanced through a patient's body lumen such asveins and arteries.

The guiding member of the present invention has an elongated core memberwith proximal and distal core sections and a flexible tubular body suchas a helical coil disposed about and secured to the distal section ofthe core member. The distal core section has a plurality of distallytapering contiguous core segments having tapers of up to 25° and lengthsof up to 15 cm. As used herein the measurement of tapers is the angle ofa line tangent to the surface of the segment in line with thelongitudinal axis of the core member. The first tapered core segment,which typically has a circular transverse cross-section, preferablytapers from the diameter of the adjacent proximal core section to adiameter of about half to about three quarters of the diameter of theadjacent proximal core section. The second tapered core segment, whichalso has a circular transverse cross-section, tapers from the smallestdiameter of the first tapered core segment to a diameter of not morethan one-half the smallest diameter of the first tapered core segment.

One presently preferred embodiment includes a first core segment with ataper in the distal direction and a distally contiguous second coresegment having a taper in the distal direction greater than the taper ofthe first core segment. The taper of the first or proximal segmentgenerally can be up to about 5°, preferably about 0.01° to about 1°,more preferably about 0.011° to about 0.2°. The taper of the second ordistal core segment can be up to about 6°, preferably about 0.01° toabout 1.1°, more preferably about 0.015° to about 0.45°.

In another presently preferred embodiment, the second tapered coresegment has a length greater than the first tapered core segment, withthe distal segment generally ranging about 1 to about 12 cm, preferablyabout 2 to about 10 cm and the distal segment generally about 1 to about8 cm, preferably about 2 to about 6 cm. The tapered core segments mayhave circular transverse cross-sections and straight exterior surfaces,e.g. frusto-conical shape. However, other shapes are contemplated, e.g.curved exterior surfaces. Indeed, the taper of the contiguous coresegments may have a continuously changing taper over all or part of bothcore segments.

The flexible tubular body such as a helical coil is secured by itsdistal end to the distal tip of the distal core section or to the distaltip of a shaping ribbon secured to the distal core section in aconventional fashion. The helical coil may be secured by its distal endby soldering, brazing or welding to form a rounded distal tip to theguiding member as done with commercially available guidewire forprocedures within a patient's coronary artery.

In one presently preferred embodiment of the invention, the guidewirehas an elongated proximal core section having a length of about 65 toabout 280 cm and a circular transverse cross-section with a diameter ofgenerally about 0.010 to about 0.035 inch (0.30-0.46 mm), typicallyabout 0.012 to about 0.018 inch (0.30-0.46 mm) for coronary anatomy.

In one presently preferred embodiment of the invention, the secondtapered core segment is preferably followed distally with a manuallyshapable flattened core segment of about 1 to 4 cm in length whichpreferably has essentially constant transverse dimensions, e.g. 0.001 by0.003 inch (mm). A helical coil having transverse dimensions about thesame as the proximal core section is secured by its distal end to theflattened distal tip of the core member, e.g. solder, and by itsproximal end at an intermediate position on the second tapered segmentso that the distal end of the second tapered segment resides within theinterior of the coil. The coil may have a length of about 2 to about 40cm or more, but typically will have a length of about 2 to about 10 cmin length.

The guidewire of the invention provides the enhanced distal and proximalsupport needed for stent deployment, advancement of atherectomy devicesand the like and provides a smooth transition between the proximal coresection and the flattened distal tip of the core member while exhibitingexcellent steerability.

In another aspect of the invention, an intracorporeal device, preferablya guidewire, has an elongated member with at least one longitudinalsection having a substantially linear change in stiffness over a lengththereof. A substantially linear change in stiffness of a section of anelongate intracorporeal device may be achieved with an elongate coremember having a tapered profile, tapering distally to a smallertransverse dimension and configured to produce a linear change instiffness. The distal taper of the elongate core may be in the form of ataper having a continuously changing taper angle, i.e. a curvilineartaper profile, or may be achieved by a plurality of tapered segmentswhich are longitudinally short in comparison to the longitudinal lengthof the tapered section as a whole.

In embodiments where a plurality of tapered segments are used, thetapered segments are preferably contiguous or adjacent each other andhave a substantially constant taper angle over the length of eachtapered segment. In a preferred embodiment, the taper angle of eachtapered segment is greater than the taper angle of the segmentproximally adjacent to it. The taper angle and segment length can becontrolled from tapered segment to tapered segment to produce thedesired bending characteristics of the longitudinal section of the coremember.

A core member may be ground to a profile which is calculatedmathematically to produce a linear change in stiffness. A useful formulafor generating a substantially linear change in stiffness is

$D_{L} = \left\lbrack {\frac{64{CL}}{E\; \pi} + D_{0}^{4}} \right\rbrack^{\frac{1}{4}}$

where D_(L) is the diameter of an elongate core member at length L froma position of starting diameter D₀, E is the modulus of elasticity ofthe material from which the elongate core member is made, and C is aconstant.

This formula may be used to generate smooth continuous profiles, ormultiple tapered segments where each individual tapered segment has asubstantially constant taper angle. In the latter instance, the taperangle and length of each tapered segment can vary to produce the overalldesired effect by having the segmented contour substantially follow theformula above. In a preferred embodiment, the points between twoadjacent tapered segments, or transition points, have diameters thatsubstantially follow the formula above for D_(L). As the number oftapered segments increases, this embodiment gradually approaches thesmooth continuous curvilinear embodiment. That is, in the limiting casewhere the number of tapered segments is large, there is little or nodifference in stiffness between the segmented core and the smoothcurvilinear profile core.

Another approach to generating linear stiffness change in an elongateintracorporeal involves controlling the moment of inertia at any givenpoint in a longitudinal section. A useful formula for such an approachis

$I_{L} = {\frac{CL}{E} + I_{0}}$

where I_(L) is the moment of inertia of the elongate core member atlength L from a position of starting inertia I₀, E is the modulus ofelasticity of the core material, and C is a constant that is derivedfrom the boundary conditions of the longitudinal section, specifically,a desired starting moment of inertia, finish moment of inertia, lengthof section of linear change in stiffness.

A core member with a linear change in stiffness over its length providesimproved advancement and control of the distal end of an intracorporealdevice through a patient's body lumen. The improvement in handlingcharacteristics results in part from the absence of abrupt changes inflexibility that can obscure the tactile feedback to the physicianholding the proximal end of the device. In addition, the abrupt changesin stiffness can cause the device to resist smooth and controllableadvancement because a step or threshold force must be applied toovercome the abrupt change in stiffness.

These and other advantages of the invention will become more apparentfrom the following detailed description of the invention when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view partially in section of a guidewireembodying features of the invention.

FIG. 2 is a transverse cross-sectional view of the guidewire shown inFIG. 1 taken along the lines 2-2.

FIG. 3 is a transverse cross-sectional view of the guidewire shown inFIG. 1 taken along the lines 3-3.

FIG. 4 is an enlarged view of the distal portion of the guidewire shownin FIG. 1 which indicates the tapers of the distal core section.

FIG. 5 is a partial elevational view of the distal core section of analternative embodiment of the invention which has a separate shapingribbon extending from the distal extremity of the core member to thedistal end of the coil.

FIG. 6 is an elevational view of a portion of a guidewire havingfeatures of the invention.

FIG. 7 is a transverse cross sectional view of the guidewire of FIG. 6taken at lines 7-7 of FIG. 6.

FIG. 8 is a transverse cross sectional view of the guidewire of FIG. 6taken at lines 8-8 of FIG. 6.

FIG. 9 is an elevational view of a portion of a guidewire havingfeatures of the invention in partial section.

FIG. 10 is an elevational view in partial section of a portion of aguidewire having features of the invention.

FIG. 11 is a graphic depiction of the diameter of a typical guidewirecore member versus the axial position or length from a fixed referencepoint of that diameter along the core member.

FIG. 12 is a graphic depiction of relative bending stiffness values of atypical guidewire core member versus length from a reference point alongthe core member.

FIG. 13 is a graphic depiction of the diameter of a typical guidewirecore member versus the length from a fixed reference point orlongitudinal position of that diameter.

FIG. 14 is a graphic depiction of relative stiffness values of a typicalguidewire core member versus longitudinal position or length along thecore member.

FIG. 15 is a graphic depiction of relative stiffness values of a typicalguidewire core member versus longitudinal position or length along thecore member.

FIG. 16 is an elevational view of a section of a guidewire havingfeatures of the invention.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1-3 depict a guidewire 10 which is a presently preferredembodiment thereof which has a core member 11 with a proximal coresection 12, a distal core section 13 and a helical coil 14. The distalcore section 12 has a first tapered segment 15 and a second tapered coresegment 16 which is distally contiguous to the first tapered coresegment. The second tapered segment 16 tapers at a greater degree thanthe first tapered segment and this additional taper provides a muchsmoother transition when the distal portion of the guidewire 10 isadvanced through a tortuous passageway. The degree of taper of the firsttapered core segment 15, i.e. the angle between the longitudinal axis 17and a line tangent to the first tapered core segment 15 is about 2° toabout 10°, whereas the taper of the second tapered core segment 16, i.e.the angle between the longitudinal axis and the second tapered coresegment is larger than the first angle and is about 5° to about 10° suchas is shown in the enlarged view of the guidewire 10 in FIG. 4. Whileonly two tapered core segments are shown in the drawings, any number oftapered core segments can be employed. Moreover, all of a multiple oftapered core segments need not have increasing degrees of tapers indistal direction. However, two or more contiguous tapered core segmentsover a length of about 5 to 15 cm should have distally increasingdegrees of tapering.

Typically, the first tapered segment is about 3 cm in length and thesecond tapered segment is about 4 cm in length. In a presently preferredembodiment, the guidewire 10 has a proximal core section 12 of about0.014 inch (0.36 mm) in diameter, the first tapered core segment has adiameter ranging from 0.014 inch down to about 0.008 inch (0.36-0.20 mm)and the second tapered core segment has a diameter ranging from about0.008 to about 0.002 inch (0.20-0.05 mm). A flattened distal tip 18extends from the distal end of the second tapered core segment 16 to thebody of solder 20 which secures the distal tip 18 of the core member 11to the distal end of the helical coil 14. A body of solder 21 securesthe proximal end of the helical coil 14 to an intermediate location onthe second tapered segment 16.

The core member 11 is coated with a lubricious coating 19 such as afluoropolymer, e.g. TEFLON® available from DuPont, which extends thelength of the proximal core section 12. The distal section 13 is alsoprovided a lubricous coating, not shown for purposes of clarity, such asa MICROGLIDE™ coating used by the present assignee, AdvancedCardiovascular Systems, Inc. on many of its commercially availableguidewires. Hydrophilic coating may also be employed.

The core member may be formed of stainless steel, NiTi alloys orcombinations thereof such as described in U.S. Pat. No. 5,341,818(Abrams et al) which has been incorporated herein. Other materials suchas the high strength alloys described in U.S. Pat. No. 5,636,641(Fariabi), which has also been incorporated herein by reference, mayalso be used.

The helical coil 14 is formed of a suitable radiopaque material such asplatinum or alloys thereof or formed of other material such as stainlesssteel and coated with a radiopaque material such as gold. The wire fromwhich the coil is made generally has a transverse diameter of about0.003 inch (0.05 mm). The overall length of the coil 14 is typicallyabout 3 cm. Multiple turns of the distal portion of coil 14 may beexpanded to provide additional flexibility.

In an alternative embodiment shown in FIG. 5, the flattened distalsegment of the core member shown in FIG. 1 is replaced with a shapingribbon 30 which is secured by its distal end to the distal end of thecoil 14 and by its proximal end to the distal extremity of the coremember 11.

While the specific embodiments described above are directed to taperedsegments with constant tapers along their lengths, the taper need not beconstant. For example, the tapers of contiguous core segments may begradually increasing in the distal direction, with the taper, i.e. atangent line, crossing the junction between the two adjacent tapersbeing a continuous function. Guidewires are generally about 90 to about300 cm in length, and most commercially available guidewires for thecoronary anatomy are either 175 cm or 190 cm in length.

Multiple tapers may be ground simultaneously or as separate operations.A centerless grinder with profile capabilities may be used to grind thetapers simultaneously. A manual centerless grinding may be employed tocreate separate tapers in separate operations. Tapers may also be formedby other means such as chemical means, e.g. etching, or laser means.

Another aspect of the invention can be seen in FIG. 6 which is a distalportion of an intracorporeal device in the form of a guidewire 40. Theguidewire 40 has an elongated core member 41, with a longitudinalsection 42, the longitudinal section having a substantially linearchange in stiffness along its length 43. The length 43 of thelongitudinal section can be up to 60 cm, preferably about 5 to about 35cm, more preferably about 10 to about 25 cm. The longitudinal section 42tapers distally to a smaller transverse dimension or diameter to a moreflexible distal segment. A flexible body 44 having a proximal end 45 anda distal end 46 is secured at its distal end 46 to a distal end 47 of adistal segment 48 of the elongate core member 41 by a first body ofsolder 51. The proximal end 45 of the flexible body 44 is secured to thelongitudinal section 42 of the elongate core member by a second body ofsolder 52.

The longitudinal section 42, and preferably the entire elongate coremember 41 of the guidewire 40 is made from high tensile stainless steel,or hi-ten 304 stainless steel. The longitudinal section 42 can also bemade from other high strength metals, some of which are precipitationhardenable, including 304 stainless steel, MP35N, L605. The longitudinalsection 42 may also be made from pseudoelastic alloys, such as NiTi. Thelongitudinal section 42 has a curvilinear profile with a smoothcontinuous change in taper angle over its length 43. The curvilinearprofile of the longitudinal section 42 preferably substantially followsthe formula

$D_{L} = \left\lbrack {\frac{64{CL}}{E\; \pi} + D_{0}^{4}} \right\rbrack^{\frac{1}{4}}$

where D_(L) is the diameter of the longitudinal section at length L froma position of starting diameter D₀, E is the modulus of elasticity ofthe core member material, and C is a constant that is determined by theboundary conditions of the longitudinal section.

The constant C is determined by the boundary conditions of a desiredsection using the equation

$C = \frac{\pi \; {E\left( {D_{L}^{4} - D_{0}^{4}} \right)}}{64L}$

where a desired starting diameter D₀, finish diameter D_(L), length ofthe section having a linear change in stiffness L, and modulus ofelasticity E of the section material are inserted into the equationwhich is then solved for C.

A typical modulus of elasticity for 304 stainless steel is approximately28×10⁶ psi. An example of a set of values for a longitudinal section 42having features of the invention are 0.002 inches for a startingdiameter D₀, 0.013 inches for a finish or ending diameter D_(L), 20 cmfor the length of the longitudinal section L, and 28×10⁶ psi for themodulus of elasticity of the core member E. Solving for C yields aconstant value of about 0.005 pound-inches. Another example of a set ofvalues for a longitudinal section 42 having features of the inventionare 0.0025 inches for a starting diameter D₀, 0.0076 inches for a finishor ending diameter D_(L), 25 cm for the length of the longitudinalsection L, and 30×10⁶ psi for the modulus of elasticity of the coremember E. Solving for C yields a constant value of about 0.00049pound-inches.

Another more generalized approach for achieving a substantially linearchange in stiffness in a longitudinal section 42 or elongate core member41 is to vary the moment of inertia along the longitudinal sectionaccording to the formula

$I_{L} = {\frac{CL}{E} + I_{0}}$

where I_(L) is the moment of inertia of the elongate core member atlength L from a position of, starting inertia I₀, E is the modulus ofelasticity of the core material, and C is a constant that is derivedfrom the boundary conditions of the longitudinal section. The constant Cis determined by inserting the values of a desired starting moment ofinertia I₀, finish moment of inertia I_(L), length of section of linearchange in stiffness L, and modulus of elasticity E into the equation andsolving for C.

The moment of inertia of a point on a longitudinal section 42 orelongate core member 41 can be varied by controlling the diameter in around cross section as discussed above. Other variations in transversecross section shape and configuration can be made in embodiments havingnon-round transverse cross sections. Finally, because bending stiffnessis equal to the modulus of elasticity multiplied by the moment ofinertia, the bending stiffness may be controlled by adjusting themodulus of elasticity along the length of a longitudinal section 42 orelongate core member 41.

FIG. 7 is a transverse cross sectional view of the guidewire 40 of FIG.6 taken at lines 7-7 of FIG. 6. The elongated core member 41 preferablyhas a round cross section. The core member 41 may optionally be coatedwith a lubricious coating 53. The coating 53 is preferably ahydrophyllic polymer, but may also be made of polymers such as TFE orthe like. FIG. 8 is a transverse cross sectional view of the guidewire40 in FIG. 6 taken at lines 8-8 of FIG. 6. The flexible body 44 is inthe form of a helical coil which is disposed about the distal segment 48of the elongate core member 41. The distal segment 48 of the elongatecore member is flattened to improve shapability of the distal segment.

FIG. 9 is an elevational view of a guidewire 60 having features of theinvention. The guidewire 60 has an elongated core member 61 with alongitudinal section 62 having a plurality of tapered segments 63tapering distally to a more flexible distal segment 64. Transitionpoints 65 are disposed between adjacent tapered segments 63. A flexiblebody member 66 is disposed over the distal segment 64 and a portion ofthe longitudinal section 62. The flexible body 66 has a proximal end 67and a distal end 68 with the distal end 68 of the flexible body beingsecured to a distal end 71 of the distal segment 64 of the elongatedcore member 61 with a first body of solder 72. The proximal end 67 ofthe flexible body 66 is secured to the longitudinal section 62 with asecond body of solder 73. In a preferred embodiment, each taperedsegment 63 of the longitudinal section 62 has a substantially constanttaper angle with the taper angle of each tapered segment being greaterthan the tapered segment proximally adjacent thereto. Preferably, thediameter of the longitudinal section 62 at the transition points 65 oralternatively midpoints 74 of the tapered segments substantially followsthe formula

$D_{L} = \left\lbrack {\frac{64{CL}}{E\; \pi} + D_{0}^{4}} \right\rbrack^{\frac{1}{4}}$

where D_(L) is the diameter of the longitudinal section at a transitionpoint at length L from a position of starting diameter D₀, E is themodulus of elasticity of the core member material, and C is a constantthat is determined by the boundary conditions of the longitudinalsection. The determination of the constant C is performed in a mannersimilar to the determination of the constant C discussed above withregard to the embodiment of FIG. 6. The tapered segments 63 of thelongitudinal section 62 or core member 61 can be up to 10 inches inlength, preferably about 0.1 to about 5 inches in length, morepreferably about 0.25 to about 3 inches in length.

FIG. 10 is an elevational view of a guidewire 80 having features of theinvention. The guidewire 80 is similar to the guidewire 40 of FIG. 6except that the elongate core member 81 does not extend to a distal end82 of a flexible body 83. Instead, a shaping ribbon 84 having a proximalend 85 and a distal end 86 has its distal end 86 secured to the distalend 82 of the flexible body 83 with a first body of solder 88. Aproximal end 91 of the flexible body 83 and the proximal end 85 of theshaping ribbon 84 are secured to a longitudinal section 92 with a secondbody of solder 93. The guidewire 80 has a longitudinal section 92configured to produce a substantially linear change in bending stiffnesssimilar to the longitudinal section 42 of FIG. 6.

FIG. 11 is a graph of values determined for a typical guidewire coremember with diameter in inches along the vertical axis and length oraxial distance from a starting point on the core member in inches alongthe horizontal axis. At the starting point A of the graph, the diameterof the core member is approximately 0.0022 inches. Point A representsthe core at a distal end of a distal segment. The distal segment of thecore member continues proximally until the distal end of the taperedlongitudinal section of the elongate core is reached, which isrepresented by point B on the graph. Moving proximally from the junctionof the distal segment and the tapered longitudinal section, the diameterof the core member increases proportionally with a length from thejunction. This type of tapered longitudinal section is representative ofa typical tapered guidewire section having a constant taper angle overthe length of the section. The taper diameter increases proximally untilthe junction between the tapered longitudinal section meets the constantdiameter section of the elongate core which is represented by point C onthe graph.

FIG. 12 is a graph of relative bending stiffness values of the elongatecore member of FIG. 11 along its axial length. As can be seen from thegraph of FIG. 12, the plot of bending stiffness of the taperedlongitudinal section starting at point B and proceeding proximally topoint C is not a straight line. There is a curvature to the plot whichbecomes progressively steeper as point C is approached. Near point C,the plot becomes quite steep, which represents an abrupt change inbending stiffness in the vicinity of point C.

FIG. 13 is a plot or graph of the diameter of a guidewire core versusthe axial position of the diameter in a core having a longitudinalsection with a substantially linear change in bending stiffness. Thegraph begins at point B at length 0 with the core member having adiameter of about 0.002 inches. Point B of FIG. 13 has a similarstarting diameter to point B in FIG. 11. FIG. 13 is representative agraph of stiffness values for an embodiment of the invention having aplurality of tapered segments, with each tapered segment having asubstantially constant taper angle. The change in diameter or taperangle of the tapered segments is greater at the distal end of thelongitudinal section and decreases proximally. The slope of the graph ortaper angle for each tapered segment is less than that of the taperedsegment that is distally adjacent. The profile of transition pointsbetween each pair of adjacent tapered segments of the longitudinalsection depicted by the graph of FIG. 13 substantially follows theformula

$D_{L} = \left\lbrack {\frac{64{CL}}{E\; \pi} + D_{0}^{4}} \right\rbrack^{\frac{1}{4}}$

where D_(L) is the diameter of the longitudinal section at a transitionpoint at length L from a position of starting diameter D₀, E is themodulus of elasticity of the core member material, and C is a constantthat is determined by the boundary conditions of the longitudinalsection.

FIG. 14 depicts typical relative bending stiffness values of a coremember versus axial or longitudinal position along the length of thecore member. The core member has a longitudinal section with a taperprofile configured to generate a linear change in bending stiffness. Theplot from point B to point C does not change appreciably in slope whichindicates a constant change in stiffness over that section. This graphis not indicative of the progressively steeper slope found on thestiffness curve of FIG. 12 where an abrupt change in stiffness is notedat point C, in addition to other points.

Bending stiffness can be measured in a variety of ways. Typical methodsof measuring bending stiffness include extending a portion of the sampleto be tested from a fixed block with the sample immovably secured to thefixed block and measuring the amount of force necessary to deflect theend of the sample that is away from the fixed block a predetermineddistance. A similar approach can be used by fixing two points along thelength of a sample and measuring the force required to deflect themiddle of the sample a fixed amount. Those skilled in the art willrealize that a large number of variations on these basic methods existincluding measuring the amount of deflection that results from a fixedamount of force on the free end of a sample, and the like. Although thegraph of FIG. 14 shows relative bending stiffness in terms of grams permillimeter, the values shown were derived from a specific test apparatususing the methods discussed above. Other methods of measuring bendingstiffness may produce values in different units of different overallmagnitude, however, it is believed that the overall shape of the graphwill remain the same regardless of the method used to measure bendingstiffness.

FIG. 15 depicts typical relative bending stiffness values of alongitudinal section of another embodiment of a core member versus axialposition along the core member. The slope of the graph from point A topoint B is essentially constant, indicating a substantially constantchange in bending stiffness from point A to point B.

Unless otherwise described herein, conventional materials andmanufacturing methods may be used to make the guiding members of thepresent invention. Additionally, various modifications may be made tothe present invention without departing from the scope thereof.

It may be desirable to have multiple tapered longitudinal sections orsections having a varied flexibility. Any combination of multiplelongitudinal sections may be used including sections having asubstantially constant taper angle, sections having a substantiallylinear change in stiffness along a length thereof, or sections ofsubstantially constant diameter along a length thereof. In FIG. 16, apreferred embodiment of an elongate core member 99 has a longitudinalsection 100 of substantially linear change in stiffness intermediate toa distal segment 101 having a substantially constant diameter and aconstant taper section 102 with a constant taper angle increasing indiameter proximally. The distal segment 101 has a diameter of about0.002 to about 0.003 inches, and a length of about 3 to about 6 cm. Thelongitudinal section 100 having a substantially linear change instiffness is about 15 to about 25 cm in length and tapers to anincreased diameter proximally from about 0.002 to about 0.003 inches ata distal end to about 0.0065 to about 0.0085 inches at a proximal end.The constant taper section 102 tapers proximally from a diameter ofabout 0.0065 to about 0.0085 inches at its distal end to an increaseddiameter of about 0.012 to about 0.014 inches at its proximal end.

1-63. (canceled)
 64. A guidewire, comprising: an elongated core memberhaving a substantially constant change in bending stiffness based onrelative bending stiffness values of the elongated core member versusaxial position values along the core member.
 65. The guidewire of claim64, wherein the slope of a graph of the bending stiffness values of theelongated core member versus the axial position values of the coremember is constant.
 66. The guidewire of claim 64, wherein the elongatedcore member is comprised of multiple core segments, at least some of themultiple core segments having a constant taper angle along a lengththereof.
 67. The guidewire of claim 66, wherein the elongated coremember has a distal end and a proximal end; the constant taper angle ofeach of the at least some of the multiple core segments being greaterthan the constant taper angle proximally adjacent thereto.
 68. Theguidewire of claim 64, wherein the elongated core member is comprised ofmultiple core segments each having a tapered segment with a constanttaper angle along a length thereof.
 60. The guidewire of claim 68,wherein each tapered segment of the multiple core segments has aconstant taper angle with the taper angle of each tapered segment beinggreater than the tapered segment proximally adjacent thereto.